Vitamin A and Response to Endotoxin

NCT ID: NCT00168649

Last Updated: 2013-11-15

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-06-30
• Study Completion Date: 2014-06-30

Brief Summary

Vitamin A given as treatment and pre-treatment has reduced the severity of symptoms after infusion with endotoxin in several animal models. We intend to examine the effect of vitamin A as pre-treatment on the response to endotoxin in humans. We furthermore wish to examine the long-term effects of vitamin A on the response to endotoxin. We hypothesise that vitamin A decreases endotoxin levels and TNF-alfa responses.

Detailed Description

Vitamin A given as treatment and pre-treatment has reduced the severity of symptoms after infusion with endotoxin in several animal models. We intend to examine the effect of vitamin A as pre-treatment on the response to endotoxin in humans. As studies in children in low-income countries have indicated that vitamin A has long-term effects on the immune system, we furthermore wish to examine the long-term effects of vitamin A on the response to endotoxin. This will be done in an established model using infusion with endotoxin to male human volunteers. We hypothesise that vitamin A decreases endotoxin levels and TNF-alfa responses. Furthermore, we hypothesise that it reduces oxidative stress and injury.

Conditions

TNF-alfa; Endotoxin Levels

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: DOUBLE

Interventions

Vitamin A

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

Inclusion Criteria: Healthy, male, between 18 and 35 years of age, non-smoker, no medicine, no infections in preceding 14 days

Exclusion Criteria:

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Uppsala University Hospital

OTHER

Sponsor Role: collaborator

Institute for Human Nutrition, Royal Veterinary School, Copenhagen, Denmark

UNKNOWN

Sponsor Role: collaborator

Bandim Health Project

OTHER

Sponsor Role: lead

Principal Investigators

Bente K Pedersen, MD, DMSc

Role: STUDY_DIRECTOR

Rigshospitalet, Denmark

Locations

Rigshospitalet, Department M7641

Copenhagen, , Denmark

Countries

Denmark

Other Identifiers

9583-2625

Identifier Type: -

Identifier Source: secondary_id

9583-2625-VITA-LPS

Identifier Type: -

Identifier Source: org_study_id